What biosimilars have been approved in the United States?

There are currently 51 biosimilars approved by the U.S. Food and Drug Administration (FDA). The most recent biosimilar approval was Hercessi (trastuzumab-strf) on April 25, 2024.

What is a Biosimilar?

According the to FDA, a biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from an existing FDA-approved reference product.

Biological products are a diverse category of products, and include therapeutic proteins (example filgrastim) and monoclonal antibodies (example adalimumab). Biological products are generally large, complex molecules, and inherent variations are normal and expected within the manufacturing process.

A manufacturer developing a biosimilar will need to demonstrate that its product is highly similar to the characteristics of the reference product in terms of purity, chemical identity, and bioactivity. The manufacturer must also demonstrate that its product has no clinically meaningful differences to the reference product in terms of safety, purity, and potency (safety and effectiveness) which is determined though human pharmacokinetic and pharmacodynamic studies, and additional clinical studies if needed.

Biosimilar products can only be dispensed in place of another biological product if the health care provider specifically prescribes the biosimilar product by name.

What is an Interchangeable?

An interchangeable product is a biological product that meets all the requirements for a biosimilar product, but also meets additional requirements outlined by the Biologics Price Competition and Innovation Act.

A manufacturer developing an interchangeable product will need to demonstrate that its product is expected to produce the same clinical result as the reference product in any given patient. If a product is to be administered to a patient more than once, the risk in terms of safety and reduced efficacy of switching back and forth between an interchangeable product and a reference product will need to have been evaluated.

Interchangeable products may be substituted at pharmacy-level without the intervention of the health care provider who prescribed the reference product. A health care provider also can prescribe an interchangeable product just like they would prescribe a biosimilar or a reference product. (Note that pharmacy laws and practices vary from state to state.)

Learn about cost-savings, clinical use, and safety of biosimilars.

Biosimilars by reference product (or by approval date)